Frequently Asked Questions About pCODR

What is the pan-Canadian Oncology Drug Review?
The pan-Canadian Oncology Drug Review (pCODR) assesses cancer drugs and makes recommendations to the provinces and territories to help guide their drug funding decisions. Established in 2010 by the provincial and territorial ministries of health, pCODR is designed to bring consistency and clarity to the assessment of cancer drugs by looking at clinical evidence, cost-effectiveness, and patient perspectives. pCODR has been a part of CADTH since April 2014.

Why was pCODR created?
pCODR is the permanent successor to the interim Joint Oncology Drug Review (iJODR), which provided evidence-based recommendations for cancer treatments from 2007 to 2011. The iJODR process demonstrated that a pan-Canadian, collaborative platform for assessing new cancer drugs provides significant value to cancer care decision-makers.

Prior to pCODR, every province and cancer agency had its own way of evaluating cancer drugs. Some evaluation processes were more defined than others. The pCODR process enables all provinces and cancer agencies to take advantage of a single approach to cancer drug evaluation, and to benefit from the same evidence and principles.

Why did pCODR become part of CADTH?
In April 2014, pCODR was transferred to CADTH to consolidate policy direction across Canada's drug review programs, and to strengthen the pCODR governance structure for long-term viability and sustainability.

How do patients benefit from pCODR?
Patients benefit because experts from across the country are involved in decisions about the treatment value and cost-effectiveness of cancer drugs. The pCODR process also ensures that scarce health care resources are used to fund the most effective cancer drugs. This benefits cancer patients and all Canadians because quality care means ensuring that the right patients receive the right treatments at the right times.

Are patient advocacy groups engaged in the pCODR process?
Yes, patient input is important to help reviewers understand the patient's point of view. Patient input allows reviewers to appreciate the impact (both good and bad) that the drug under review may have on those taking it and those caring for patients living with cancer.

How can the general public find information about pCODR reviews?
Drug funding recommendations, as well as the clinical and economic reports that are considered in formulating recommendations, are posted publicly on cadth.ca. This enables CADTH to meet its commitment to transparency in the drug review process.

Does CADTH accept pCODR submissions for review before Health Canada approval so funding recommendations can be made at, or as soon as possible after, Health Canada approval?
As part of CADTH's commitment to reviewing cancer drugs in a timely manner, we accept submissions for drugs before they receive Health Canada approval; in other words, prior to a drug receiving its Notice of Compliance (NOC).

Does CADTH offer a pCODR appeals process if manufacturers do not agree with recommendations?
Parties that contribute from the start of a submission's review process have options to comment on the resulting recommendation. Different options are available depending upon whether the recommendation is initial or final. These options are reconsideration, resubmission, and procedural review.

Initial Recommendation — Options for Stakeholders
An Initial Recommendation provides contributing stakeholders (e.g., the manufacturer, any contributing patient advocacy group, and the Provincial Advisory Group) with an opportunity to share their interpretations and perspectives on a pCODR Expert Review Committee (pERC) recommendation.

If the parties who contributed at the start of the initial process are not in agreement with some or all of the recommendation, then the drug submission must go through the reconsideration step. Reconsiderations allow for specific public consultations and feedback to be provided on an initial recommendation prior to it becoming final.

Final Recommendation — Options for Stakeholders
After a Final Recommendation has been issued, the manufacturer may request a resubmission. This is permitted if new information emerges and the manufacturer believes that the information will likely change the pERC recommendation.

For example, new clinical information (not previously submitted or published) in support of improved efficacy or safety will be considered, as will new cost information (not previously submitted or published) that significantly impacts the cost-effectiveness of the drug.

Procedural Review
Once a Final Recommendation is issued, if a manufacturer believes that the pCODR process was not followed, then the manufacturer may consider making an application for a procedural review. A request for a procedural review may be submitted on the grounds that pCODR failed to act in accordance with its own procedures in conducting the review, or that pERC failed to apply its deliberative framework in formulating the pERC Final Recommendation. Please note that these grounds relate only to whether or not the process was followed and not to the content of the pERC final recommendation. More details are available in the Procedural Review Guidelines.

How long does it take to complete a pCODR submission review?
On average, the review process takes from five to eight months to complete. This ensures that the review is rigorous, consistent, and evidence-based. It also provides sufficient time for input from patient advocacy groups and drug manufacturers. Some reviews may take longer to complete because of a variety of factors; for example, a higher volume of submissions under consideration or the need for a particular mix of experts and resources. To support a timely review process, we encourage manufacturers to make a submission prior to Health Canada approval (pre-NOC).

Does CADTH have hard deadlines for completing pCODR reviews and making recommendations?
Yes, there are publicly posted timelines for each submission review. If a change occurs to the schedule, new timelines are posted, along with an explanation.

What are the committees and panels that assist pCODR with its work?
Full details on our committees and panels can be found in the Advisory Bodies section of cadth.ca.

How are people named to pCODR's expert panels?
The 16 members of the pCODR Expert Review Committee (pERC) are selected based on applications received through a formal nomination and selection process. When needed, a call for nominations occurs through each of the provinces and cancer agencies, and through posting on cadth.ca. The pERC Chair has a special nomination and selection process given the importance of this crucial leadership role. The patient members of pERC also have a separate nomination and selection process, which is conducted with the help of an external recruitment agency. Patient groups had an opportunity to provide input on the selection criteria for patient members. Both industry and patient groups can nominate individuals for the pERC professional members.

Are the provinces and territories using pCODR recommendations to make their funding decisions?
There are many factors that go into the decision of a province, territory, or cancer agency to fund a cancer drug. These include, but are not limited to, its specific patient population, available budget, and local health system priorities. A pCODR recommendation is one of the many factors that will be considered prior to a funding commitment.

There is a strong commitment to the collaborative effort of pCODR, as demonstrated by monthly Provincial Advisory Group (PAG) meetings, where issues of recommendation implementation are actively discussed. That being said, any questions you may have about specific funding decisions should be referred to your particular health ministry or cancer agency.

How can I find out if my province or territory has made any funding decisions about a specific cancer drug based on pCODR's recommendation?
The Provincial Funding Summary publicly reports the funding decisions made by each participating province for each drug that has completed the pCODR review process. To locate this information, first search cadth.ca for the drug in question. You will find a link to the drug's Provincial Funding Summary on the page devoted to the drug. This initiative is part of our commitment to introducing greater transparency and clarity to the cancer drug review process. The Provincial Funding Summaries are updated monthly as new information becomes available.

How does the Provincial Funding Summary benefit patients in need of treatment?
A summary of each participating province's funding decision will help bring greater transparency and clarity to the cancer drug review process. With the Provincial Funding Summary, you can find out how a cancer drug is being funded in the participating provinces and territories. Patients will need to contact their ministry of health or cancer agency to determine their own eligibility for public funding.